VenaSeal™ Closure System

FDA Premarket Approval P140018 S035

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceVenaSeal™ Closure System
Generic NameAgent, Occluding, Vascular, Permanent
ApplicantMEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP140018 Supplement NumberS035 Date Received10/12/2022 Decision Date11/08/2022 Product Code PJQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-12
Decision Date2022-11-08
PMAP140018
SupplementS035
Product CodePJQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMEDTRONIC VASCULAR INC
3033 Campus Drive
plymouth, MN 55441 PMA NumberP140018 Supplement NumberS035 Date Received10/12/2022 Decision Date11/08/2022 Product Code PJQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
updates To The Visual Inspection Criteria For The VenaSeal Adhesive Vials

Supplemental Filings

Supplement NumberDateSupplement Type
P140018Original Filing
S035 2022-10-12 30-day Notice
S034 2022-08-15 30-day Notice
S033
S032 2022-04-29 Real-time Process
S031 2022-01-21 30-day Notice
S030 2021-11-30 30-day Notice
S029
S028 2021-09-23 30-day Notice
S027
S026
S025 2021-04-23 Special (immediate Track)
S024
S023 2021-02-25 30-day Notice
S022
S021 2020-10-19 Real-time Process
S020 2020-08-24 30-day Notice
S019 2020-03-10 Special (immediate Track)
S018 2019-10-28 Normal 180 Day Track
S017 2019-09-25 Real-time Process
S016 2019-08-09 30-day Notice
S015 2019-05-24 30-day Notice
S014 2018-11-16 30-day Notice
S013 2018-09-24 30-day Notice
S012 2018-08-10 30-day Notice
S011 2018-03-27 30-day Notice
S010 2018-03-05 30-day Notice
S009 2018-02-26 30-day Notice
S008 2017-08-04 Normal 180 Day Track
S007 2017-06-13 Special (immediate Track)
S006 2017-05-18 Normal 180 Day Track No User Fee
S005 2016-11-01 30-day Notice
S004 2016-09-07 Normal 180 Day Track No User Fee
S003 2016-07-26 30-day Notice
S002 2016-06-27 30-day Notice
S001 2015-07-28 Real-time Process

NIH GUDID Devices

Device IDPMASupp
20643169986262 P140018 006
00763000240776 P140018 018

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.